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TITLE 55. HUMAN SERVICESCHAPTER 5200 PSYCHIATRIC OUTPATIENT CLINICSCOMPLIANCE GUIDEOffice of Mental Health and Substance Abuse Services(OMHSAS)
INTRODUCTIONOn October 12, 2019, 55 Pa. Code Chapter 1153 (relating to outpatient behavioral healthservices) and 55 Pa. Code Chapter 5200 (relating to psychiatric outpatient clinics) becameeffective. These regulations govern the payment and operation of psychiatric outpatient clinicsin the Commonwealth of Pennsylvania. In most cases, the regulations speak for themselves.There are, however, some regulations that require additional clarification. Even when themeaning of a regulation is very clear, the purpose and intent of the regulation may not be.There are also different ways to measure regulatory compliance, and both operators andOMHSAS Licensing Representatives need to know how compliance will be determined. Thisguide is meant to help operators and OMHSAS Licensing Representatives better understandthe regulations.This guide is a companion piece to 55 Pa. Code Chapter 5200; it should be used alongwith the regulations, not instead of them. The explanatory material in this guide is not meantto be “new regulations” or to extend meaning of the regulations beyond their original intent.In addition, this guide has been developed to provide clear explanations of the regulatoryrequirements of 55 Pa. Code Chapter 5200 to help psychiatric outpatient clinic operatorsprovide safe environments and effective services to individuals through regulatorycompliance, and to help regulators protect individuals by conducting consistent andcomprehensive inspections. It provides a detailed explanation of each regulatory requirement,including expectations for compliance, guidelines for measuring compliance, and the primarypurpose for the requirement. Finally, this guide includes general regulatory requirements andprocedures, a glossary of regulatory terms, and overviews of complex regulatory issues toprovide a more global understanding of the chapter and its purpose.Page 2 of 57
Table of ContentsREGULATIONPART 1: An Introduction and Overview of Regulatory ProcessPAGE1How to Use the Regulatory Compliance Guide2Overview of the Licensing Process3The Plan of Correction5Waivers8Occupancy Permits9PART 2: Regulations, Discussions, and Inspection Procedures10GENERAL PROVISIONS11§ 5200.3. Definitions.11§ 5200.5. Application and review process.14ORGANIZATION15§ 5200.11. Organization and structure.15§ 5200.12. Linkages with mental health service system.16STAFFING AND PERSONNEL18§ 5200.21. Qualifications and duties of the director/clinical supervisor.18§ 5200.22. Staffing pattern.20§ 5200.23. Psychiatric supervision.24§ 5200.24. Criminal history and child abuse certification.26TREATMENT STANDARDS28§ 5200.31. Treatment planning.28§ 5200.32. Treatment policies and procedures.33§ 5200.33. Discharge.34MISCELLANEOUS PROVISIONS35Page 3 of 57
§ 5200.41. Records.35§ 5200.42. Medications.37§ 5200.43. Fee Schedule.39§ 5200.44. Quality assurance program.39§ 5200.45. Physical facility.40§ 5200.46. Notice of nondiscrimination.43§ 5200.47. Other applicable regulations.43§ 5200.48. Waiver of standards.44MOBILE MENTAL HEALTH TREATMENT45§ 5200.51. Provider service description.45§ 5200.52. Treatment planning.46Part 3: Additional Resources48Bureau of Equal Opportunity49Civil Rights Compliance Contact InformationElectronic Record Keeping50Shared Space/Co-Location Attestation51Shared Space/Co-Location Attestation Form52Page 4 of 57
PART 1:An Introduction and Overviewof the Regulatory ProcessPage 5 of 57
How to Use the Regulatory Compliance GuideThis guide has been developed to provide clear explanations of the regulatory requirementsof 55 Pa. Code Chapter 5200 to help licensed operators provide safe environments andeffective services to individuals in treatment through regulatory compliance, and to helpOMHSAS Licensing Representatives protect these individuals by conducting consistent andcomprehensive inspections. This guide provides a detailed explanation of each regulatoryrequirement, includes explanations for compliance, guidelines for measuring compliance, andthe primary benefit of the requirement.Each regulation that can be measured during an inspection is included in the RegulatoryCompliance Guide (RCG) and is accompanied by clarifying information. The illustration belowshows how regulations are presented and how OMHSAS Licensing Representatives andproviders can effectively use the RCG.This area lists the regulation exactlyas it appears in § 5200.The “Discussion” section providesinformation about applying theregulation, including referencing otherregulations and applicable narratives.The “Inspection Procedures” sectiondescribes how Representativesmay measure compliance with theregulation.The “Primary Benefit” sectionexplains how the regulation protectsindividuals in treatment, including:health, safety, and well-being.Regulation: § 5200.12. Linkages with mental health system.(a) A psychiatric outpatient clinic requires a close relationshipwith an acute psychiatric inpatient service and a provider ofemergency examination and treatment. A written statementdescribing the accessibility and availability of the services toindividuals is required and shall be maintained on file at thepsychiatric outpatient clinic and updated as needed.Discussion: It is recommended by OMHSAS to update linkageagreements at least every three years to ensure linkages arecurrent and providers are still operational.Inspection Procedures: OMHSAS Licensing Representativeswill review the facility’s linkage agreements.Primary Benefit: Establishing close relationships with otheragencies helps to ensure that individuals served by the facilityreceive the appropriate agency services that are needed.Written statements describing the accessibility and availabilityof the services to individuals helps to make certain that thefacility has a plan in place for effective delivery of services.“Recommended”Throughout the RCG the word “recommended” is seen repeatedly. This word indicates thatwhat is written is a suggestion based on best practices, not a regulatory requirement. Failureto follow a recommendation will not result in a regulatory violation.Inspection ProceduresPlease note that the “Inspection Procedures” are guidelines, and the specific means ofmeasuring compliance with a regulation may differ depending on circumstances specific tothe facility, the reason for the inspection, and the nature of the regulatory violation.Page 6 of 57
Overview of the Licensing ProcessThe following section outlines the processes that OMHSAS Licensing Representatives willfollow, as the situations allow, for initial, annual and unannounced licensing visits.Licensing Visit PreparationPrior to the licensing visit, OMHSAS Licensing Representatives will provide the PsychiatricOutpatient Clinic with the following: A letter/e-mail confirming the date and time of the licensing visit, and providesa list of documents that will need to be reviewed when on-site.A confirmation of location where the licensing visit will occur and a request fora workspace in the facility where OHMSAS Licensing Representatives may workin private. If the clinic maintains electronic records, a computer to access theserecords must be available for each representative who will be present.Pre-inspection documents including the program information form and CPSLtracking form (if applicable). The agency must complete and return to theOMHSAS Licensing Representative prior to the licensing visit.Conducting the Entrance ConferenceDuring the entrance conference, OMHSAS Licensing Representatives will: Facilitate introductions that include name and title.OMHSAS Licensing Representatives will wear Commonwealth ID badges in a conspicuousplace at all times while on-site for the benefit of facility staff and individuals. Briefly state the purpose of the inspection. Discuss the agenda for the day. Request a point of contact and discuss a way to maintain communication throughoutthe visit. Provide an opportunity for the director or clinical supervisor to give updates on theprogram to inform of any changes, issues, successes that occurred since the previouslicensing visit, and ask any questions. Discuss waivers or policy updates as needed.Source of InspectionCompliance with regulations can be measured through three methods: “On-site” – Direct observation during an on-site inspection. This includes directobservation using all five senses. Site observations include, but are not limited to, thephysical inspection of staff offices, conference rooms, waiting room, rooms used toprovide therapy, room where medication may be stored and/or dispensed. This isconducted to assure compliance with Federal, State and local requirements for safety,fire, accessibility, health, and medication.“Records” – Inspection of written documents. This may include, but is not limited to,inspection of written and electronic materials, photographs, and other paper andelectronic materials.“Interview” – Asking questions for further insight into how services are provided andhow regulatory requirements are met. This may include, but is not limited, to thefollowing: Directors, Supervisors, staff members, and individuals receiving treatment.Page 7 of 57
RecordsThe following minimum number of records for staff and individuals in treatment must bereviewed for each facility. Additional records should be reviewed if there is reason to suspectviolations, or if the minimum sample is not representative of the population served or of thevarious staff positions.For records of individuals in treatment, a variety of records are selected to provide anaccounting of the different services and populations served by the facility. Selected recordswill account for, but are not limited to, the following: main location and satellite locations,therapy and medication management only, site-based and mobile therapy, adult andchild/youth/young adult. The OMHSAS Licensing Representatives assigned to work with thefacility will request information prior to the inspection to help in their selection of individualrecords. OMHSAS Licensing Representatives will review a minimum of 12 individual records. Ofthese 12, two must be records of individuals who have been discharged.OMHSAS Licensing Representatives will review additional files as necessary for avariety of other factors.For staff records (HR files), OMHSAS Licensing Representatives review these records todetermine whether staff meet position qualification requirements, and have all requiredclearances and trainings. For newly licensed programs, all staff records will be reviewed during the initial sitevisit.For established programs, the staff records of all staff members who have been hiredor promoted in the time period following the previous site visit will be reviewed. Thisincludes any staff member who has left the agency during this timeframe. At least 10percent of all tenured staff files should be reviewed.OMHSAS Licensing Representatives will review additional files as necessary for avariety of other factors.OMHSAS Licensing Representatives will also review additional records; these records will beeither requested prior to, or during the on-site inspection. This includes, but is not limited to,the following: current description of services, organizational chart, current waivers, changesin policies and procedures, documentation of trainings and supervision, quality improvementplans and reports, and current linkages agreements.Conducting the Exit ConferenceIf the inspection will last more than one day, OMHSAS Licensing Representative will conducta partial exit conference with the director or clinical supervisor at the end of each day on-site.OMHSAS Licensing Representatives will explain the progress of the inspection, including whathas been and what remains to be done and when OMHSAS will return to complete theinspection.Prior to conducting the final exit conference, OMHSAS Licensing Representatives will: Review the program using the outpatient survey tool to ensure that compliance hasbeen measured in all areas. Confer with any accompanying OMHSAS Licensing Representatives on preliminaryfindings (strengths, recommendations, citations)Page 8 of 57
Notify the facility of the time and place of the exit conference at least one hour priorto the full exit conference, whenever possible.During the final exit conference, OMHSAS Licensing Representatives will: Allow the facility to include any staff they wish to have present. Allow the facility a chance to provide additional information or clarification whenneeded. Remind attendees that the purpose of the conference is to provide preliminary findings. Review each citation found, provide the rationale for each regulation cited, providetechnical assistance, and discuss the Plan of Correction (POC) process. Explain that all citations must be reviewed by an OMHSAS supervisor before beingrecorded on a written licensing inspection summary (LIS) and sent to the facility. Refer to appropriate local or state training sources, as needed. Provide forms, technical assistance materials, and other documents to assist withcompliance. Explain the next steps in the license process (preparation and mailing of the LIS, POCsubmission by the facility, review of POC, follow-up on the POC as needed,recommendation re: licensure). Explain that the OMHSAS Community Program Managers/Regional Director makes alldecisions regarding license issuance or enforcement action.During the final exit conference, OMHSAS Licensing Representatives will NOT: Make preliminary recommendations for licensing actions (i.e. issuance of a provisionallicense). Speculate regarding possible licensing outcomes. Make statements of value judgments about the facility’s appearance, operations, orstaff.Frequency of OMHSAS Inspections of Primary and Satellite LocationsWhile the regulation uses the term “site” related to a facility, it is common practice thatOMHSAS licensing representatives use the term “satellite” or “satellite site” for any cliniclocations that are not deemed the primary location on the certificate of compliance.OMHSAS licensing staff are required to inspect the licensed organization annually. They areadditionally expected to ensure all facilities, including the primary location and satellites, arereviewed at least every three years. However, clinic sites that administer medications shouldbe seen annually. OMHSAS licensing staff may rotate the location at which they complete theyearly onsite inspection to ensure all sites are seen within the three-year period.The Plan of CorrectionThe Department of Human Services (DHS) has created a consistent approach to licensingthroughout DHS which assures that every plan of correction (POC) is implemented timely toprotect the ongoing safety and well-being of those served by a program. This process isoutlined in DHS Bulletin 14-Bul-107 and below.The Plan of Correction Process1. If any licensing violations are found during an on-site inspection or investigation, anLIS with identified deficiencies will be issued. An attempt will be made to issue the LISwithin 15 business days of the date of the exit conference.Page 9 of 57
2. In response to the LIS, the program shall return an acceptable POC to the assignedOMHSAS Licensing Representative no later than 10 calendar days after the LIS wassent to the program. Based upon the violation, OMHSAS may request the POC besubmitted earlier than 10 calendar days after the LIS was sent to the program.3. An acceptable POC must include, at a minimum, concrete and measurable correctiveactions to address each specific violation, including any measures or systemic changesto ensure the licensing violation will not reoccur.4. OMHSAS either accepts or does not accept the POC. OMHSAS will attempt to acceptor not accept the POC within 10 business days of receipt of the POC.5. If OMHSAS does not accept the POC, then the program shall submit a second, revisedPOC. The program should submit the second, revised POC within five business days(or less if OMHSAS determines it necessary) of the date of the notice that the first POCwas unacceptable.6. Upon receipt of the second, revised POC, OMHSAS either accepts or does not acceptthe POC. OMHSAS will attempt to accept or not accept the second, revised POC withinfive business days of the receipt of the second, revised POC.7. If OMHSAS does not accept the second, revised POC, then OMHSAS may direct thePOC, or may take further licensing action, which could include revocation ornonrenewal of the Certificate of Compliance (COC), or issuance of a provisional COC.OMHSAS will attempt to notify the program within 10 business days from the date thesecond POC was determined not acceptable.8. Upon acceptance of the POC, OMHSAS will send a written notification to the programthat the POC is acceptable. OMHSAS’ acceptance of a POC only serves as OMHSAS’acknowledgement of the program’s willingness to adequately and timely correct thelicensing violations. Acceptance of a POC did not and does not absolve the program ofthe obligation to achieve and maintain compliance, nor does it confirm that theprogram is compliant with licensing requirements.9. OMHSAS verifies compliance by an on-site reinspection or by reviewing documentationthat was submitted by the program and that conclusively demonstrates the POC wasimplemented, compliance was achieved and is being maintained.10. The timeframe for verification of compliance should be based upon how the regulatoryviolations may impact the health and safety of individuals. OMHSAS will attempt to reinspect those violations that pertain to serious health and safety issues within fivebusiness days after the implementation date of the POC for that specific violation. Forall other compliance issues, OMHSAS will attempt to re-inspect or review documentswithin 30 calendar days after the last implementation date specified in the POC. Byway of further explanation on the 30-day timeframe, if a POC contains multiple itemsand plans responsive to an LIS, then the latest date should be used when determiningthe timeframe for completing the re-inspection. Nothing in this guidance precludes anOMHSAS Licensing Representative from conducting on-site monitoring visits before thespecific implementation date of the POC or any item within the POC.Page 10 of 57
11. If, upon reinspection or document review, OMHSAS finds that the program hasachieved and is maintaining compliance, then OMHSAS will notify the program inwriting and issue a new annual COC. OMHSAS will also update, accordingly, anydocuments posted to the web to indicate that the plan of correction has beenimplemented and the licensee has achieved compliance.12. If OMHSAS finds that a POC has not been fully implemented or the program has notachieved and maintained compliance with any licensing requirements, then OMHSASwill issue a provisional COC unless there is an extraordinary circumstance.Please note, nothing in this process limits OMHSAS in any way from taking other licensingaction, as OMHSAS finds appropriate, pursuant to applicable law.Elements of an Acceptable Plan of CorrectionRegulations are necessary to ensure the safety and well-being of those that we serve. It isimportant that this is kept in mind as an agency writes a POC. To help provide all the elementsneeded in a Plan of Correction, the following sections have been created to assist an agencywrite an acceptable POC.Why did it happen? Understanding why the violation happened is critical to keep it fromhappening again. Sometimes the most easily identifiable cause may not be the real reasonthe violation occurred. One way an agency can identify the root cause of the problem is byasking “Why” multiple times. This is a very simple approach for identifying each violation’ssource.What do you do now to fix the problem? When writing the immediate solution, it shouldaddress who is responsible for fixing the problem and monitoring compliance, what actionthat person will take, and when that action will happen. The solution needs to be realistic,sustainable, and specific.How do you prevent this from happening again? The goal of the POC is not only to fix theviolation, but make sure there is a sustainable plan in place to keep it from happeningagain. These long-term solutions should greatly reduce or eliminate the chances of theviolation happening again and do it in a manner that is sustainable over time. The POCshould detail specific, realistic, actionable steps that keep the violation from happeningagain.Provider’s Plan of Corrective Action / Projected Dates of Completion. The provider’s plan ofcorrective action includes itemized steps that are needed to fix the violation and keep itfrom happening again. It clearly denotes each specific, realistic, and actionable step, andthe person responsible for implementation of each step. The projected dates of completionis the date that each step will be completed.Page 11 of 57
WaiversOccasionally, a psychiatric outpatient clinic is unable to comply with a regulation due to thestructure, operation, or population served. It is for this reason that psychiatric clinics arepermitted to request waivers of certain regulations. When waivers are issued, additionalconditions may apply. Psychiatric clinics must comply with all regulations unless a waiver hasbeen approved. Submitting a request for a waiver does not permit noncompliance, nor is aplan to submit a waiver an acceptable plan of correction for a regulatory violation.Requesting a WaiverTo request a waiver, a program shall submit a waiver request that outlines the followinginformation:1.2.3.4.5.6.7.8.The facility or agency’s name and address.The number on the Certificate of Compliance, when applicable.Citation to the Pa. Code or Bulletin section from which the waiver is requested.The citation to the Pa. Code or Bulletin section that permits the requested waiver.The period of time covered by the requested waiver.The reason the facility or agency is requesting the waiver.Detailed justification for granting the waiver request.Explanation with concrete assurances how the health, safety and welfare ofindividuals will be safeguarded during the proposed period of the waiver.9. Measures taken to meet the purpose of the regulation throughout the proposedperiod of the waiver.10. Measures taken or planned to reestablish compliance with the regulation aswritten.Agencies must submit the request for a waiver to the County MH/IDDD Administrator of eachcounty the agency serves or will serve. Agencies must include the written response from theMH/IDDD Administrator(s) with the waiver request and submit them to the regional OMHSASField Office.OMHSAS will make a decision to approve or deny the waiver as soon as operationally possible.Determinations may be delayed or denied if all of the information required is not included inthe waiver request.Facilities and agencies should not consider the submission of a waiver request to mean thatit is approved and that they are excused from following the regulation. Instead, facilities oragencies must comply with the regulation as it is written unless and until they receive awritten notice that the waiver has been approved, along with any additional conditions of theapproval.The Waiver DecisionIf the waiver is granted, the Department will specify the length of time for which the waiveris granted and any conditions that the facility must meet.If the waiver is denied, facilities have the right to appeal. Instructions for filing an appeal willbe included in the denial letter.Page 12 of 57
Waiver Denials, Renewals, and RevocationsAgencies may also request renewal of an approved waiver. It is recommended that requestsfor continuation of the waiver be submitted to the assigned OMHSAS Licensing Representative60 days in advance of the approved waiver’s expiration date or 60 days prior to the date oflicense renewal, whichever is earlier to be consistent with 55 Pa. Code Chapter 20requirements around reapplication. Requests for renewal must contain all information listedabove, including a letter of support from the County MH/IDD Administrator(s).Agencies may appeal adverse rulings (such as denials) regarding requests for waiver. Appealsare directed to:OMHSAS Bureau of Policy, Planning & Program DevelopmentATTN: Waiver AppealsP.O. Box 2675Harrisburg, Pennsylvania 17105Or: RA-PWBPPPD@pa.govAny appeal must be in writing and must be received within 30 days of the mailing date of theletter being appealed.The Department may revoke a waiver at any time if the conditions required by the waiver arenot met, if conditions have not been met on a continual basis or if there is a risk to the health,safety, or well-being of the individuals served.Occupancy PermitsAgencies that wish to begin providing services, or wish to provide services at a location thatis not on their current certificate of compliance, must submit an occupancy permit for thisnew location. The address on the occupancy permit address must exactly match the addressof the location where the services will be provided. A post office box is not accepted for aprogram facility address; rather, the street address is required. If the address has beenchanged, the agency should speak with either the Post Master or Emergency Medical Services(911 change) and request this be explained in written form. The agency could also check withthe county organization that issued the permit to verify whether it has a permit with theupdated address. Occupancy permits must have at a minimum the address of the structure,the name of the building official, the use code, and the maximum occupancy. One of thefollowing is required for the main site and satellites: A copy of the Department of Labor and Industry (L&I) Certificate. Pittsburgh, Philadelphia, Scranton or participating Municipality Occupancy Certificate (afterApril 9, 2004) under the Uniform Construction Code (UCC) for the building in which theprogram is located. A list of UCC participating municipalities is available online. A report from a private inspection service stating the results of its review, along with thecredentials of the inspector and the criteria by which the review was conducted.Page 13 of 57
PART 2:Regulations, Discussion,and Inspection ProceduresPage 14 of 57
GENERAL PROVISIONSRegulation: § 5200.3. Definitions.Advanced practice professional—A person who holds a current Pennsylvania licenseas a certified registered nurse practitioner or a physician assistant and:(1) Holds a mental health certification, or(2) Obtains a mental health certification within 2 years of being hired by thepsychiatric outpatient clinic or by July 30, 2020, whichever is later.Discussion: OMHSAS will accept the following certifications at this time and will considerother certifications based upon review of the qualifications and experience on a case bycase basis.Certified Registered Nurse Practitioner CertificationsPennsylvania Department of State approved certifications: Adult Psych Mental Health Family Psychiatric Mental Health Psychiatric Mental HealthNational Certifications in Psychiatric-Mental Health issued by: The American Nurses Credentialing Center (ANCC)Completion of a psychiatric-mental health program accredited by: The Commission on Collegiate Nursing Education (CCNE) The Accreditation Commission for Education in Nursing (ACEN) The National League for Nursing Accrediting Commission (NLNAC)Pediatric Nursing Certification Board certification: Pediatric Primary Care Mental Health Specialist CertificationPhysician Assistant CertificationNational Commission on Certification of Physician Assistants: Certificate of Additional Qualification (CAQ) in PsychiatryCertifications are renewed on a two-year cycle.Advanced practice professionals that do not have a mental health certification may not becounted towards the agency overall psychiatric hours required per the regulation.Inspection Procedures: OMHSAS Licensing Representatives will review the staff recordto verify staff member has a required license and certification to be considered an advancedpractice professional.Primary Benefit: Programs are allowed to utilize advanced practice professionals toprovide services which historically were provided only by physicians. The expanded poolof professionals who can provide these services will increase access to individualsreceiving services in the outpatient setting. The requirement that advanced practiceprofessionals have a mental health certification assures they have the knowledgenecessary to perform these services.Page 15 of 57
Regulation: § 5200.3. Definitions.Mental health professional—A person who meets one of the following:(i) Has a graduate degree from a college or university that is accredited by an agencyrecognized by the United States Department of Education or the Council for HigherEducation Accreditation (CHEA) in a generally recognized clinical discipline inwhich the degree program includes a clinical practicum.(ii) Has an equivalent degree from a foreign college or university that has beenevaluated by the Association of International Credential Evaluators, Inc. (AICE)or the National Association of Credential Evaluation Services (NACES). TheDepartment will accept a general equivalency report from the listed evaluatoragencies to verify a foreign degree or its equivalency.(iii) Is licensed in a generally recognized clinical discipline that includes mentalhealth clinical experience.Discussion: The October 12, 2019, update to § 5200 added a requirement that mentalhealth professionals who meet qualifications by subsection (i) should have a graduatedegree that includes a clinical practicum. OMHSAS has decided to legacy in mental healthprofessionals who have graduate degrees without a clinical practicum hired prior to thepublication of the regulation update, how
On October 12, 2019, 55 Pa. Code Chapter 1153 (relating to outpatient behavioral health services) and 55 Pa. Code Chapter 5200 (relating to psychiatric outpatient clinics) became effective. These regulations govern the payment and operation of psychiatric outpatient clinics in the Commonwealth of Pennsylvania.
